Diagnosing Dx

In this episode of Diagnosing Dx, David Filby is joined by Kavya Swaminathan, PhD, Co-Founder and CEO of Kascaid.

An immunologist and proteomics scientist by training, Kavya has spent her career studying immune dysregulation and biomarker discovery. That experience led to Kascaid and a fundamental question: can we understand chronic immune disease better by measuring what is happening far more frequently?

Kavya explains why the company is turning to interstitial fluid (ISF) as an alternative to traditional blood sampling, and how higher-frequency immune measurements could help clinicians understand treatment response, detect disease changes earlier and move away from today’s trial-and-error approach to care.

We also discuss Kascaid’s plans for at-home sampling, its longer-term ambition to build a longitudinal immune data layer, and how partnerships with patients and clinicians are shaping the product from the earliest stages.

Key takeaways:
🔹 Why chronic immune disease needs more frequent and actionable biomarker data
🔹 The limitations Kavya sees in conventional blood-based immune measurements
🔹 Why interstitial fluid could enable higher-frequency monitoring
🔹 How Kascaid is initially focusing on treatment response and disease progression
🔹 Why longitudinal immune data could eventually support earlier diagnosis and more precise treatment

Chapters:
01:07 Introduction
02:43 Kavya’s journey from immunology to diagnostics
07:08 Kascaid and the chronic immune disease problem
10:39 Why interstitial fluid instead of traditional blood testing?
15:06 Monitoring treatment response more frequently
19:26 Building a longitudinal immune data layer
25:05 Company milestones, partnerships and early validation
32:40 FDA, reimbursement and the path to market

Guest: Kavya Swaminathan, PhD
Co-Founder & CEO, Kascaid
LinkedIn: https://www.linkedin.com/in/kavya-swaminathan/

Host: David Filby
Founder and CEO of Elevra Consulting
LinkedIn: https://www.linkedin.com/in/davidfilby/

🔔 Subscribe to Diagnosing Dx for weekly conversations with leaders shaping the future of diagnostics and omics.

In this episode of Diagnosing Dx, David Filby is joined by Paul Kase, Chief Commercial Officer at Lumos Diagnostics.

Paul brings 30 years of healthcare experience, including more than 20 years in rapid point-of-care diagnostics. His history with FebriDx stretches back to its earliest development, and he now leads commercialisation as Lumos enters a major new phase following its US CLIA waiver.

Paul explains how FebriDx uses two host-response biomarkers to help differentiate bacterial from non-bacterial infections from a finger-stick blood sample in around 10 minutes, without instrumentation.

We also discuss antibiotic stewardship, reimbursement, integrating novel tests into existing clinical workflows, and the commercial strategy Lumos is using to drive adoption across urgent care and primary care.

Key takeaways:
🔹 Why the CLIA waiver represents such an important commercial milestone for FebriDx
🔹 How CRP and MxA are used to differentiate bacterial from non-bacterial infection
🔹 Why overlapping respiratory symptoms can contribute to unnecessary antibiotic prescribing
🔹 The three pillars Paul believes every novel point-of-care diagnostic needs to address
🔹 How Lumos is approaching reimbursement, distribution and adoption in the US

Chapters:
01:07 Introduction and Paul Kase’s background
05:43 Lumos Diagnostics and the FebriDx CLIA waiver
08:03 How FebriDx works and the unmet need
09:54 Changing the respiratory testing workflow
14:27 Clinical utility, workflow and reimbursement
20:21 Commercialisation, adoption and distribution
25:14 International expansion and future markets
30:53 Future milestones and driving commercial growth

Guest: Paul Kase
Chief Commercial Officer, Lumos Diagnostics
LinkedIn: https://www.linkedin.com/in/paul-kase-8bb96159/

Host: David Filby
Founder and CEO of Elevra Consulting
LinkedIn: https://www.linkedin.com/in/davidfilby/

🔔 Subscribe to Diagnosing Dx for weekly conversations with leaders shaping the future of diagnostics and omics.

In this episode of Diagnosing Dx, David Filby is joined by Marty Keiser, Founder and CEO of IVBH.

After beginning his career in asset management and capital markets, Marty moved into biotech eight years ago with a focus on blood-based molecular diagnostics and early disease detection. That outside perspective shaped how he built IVBH, borrowing ideas from industries beyond diagnostics to create a different model for developing and scaling diagnostic companies.

Marty explains IVBH’s studio model, the science behind its cell-free RNA platform, and how its health franchises are developing tests across breast cancer, lung cancer and metabolic liver disease.

We also discuss why traditional diagnostics business models can struggle, the growing opportunity for cash-pay and consumerised testing, and what helped Mammogen secure institutional Series A funding in a difficult market.

Key takeaways:
🔹 Why Marty believes the traditional diagnostics business model needs to evolve
🔹 How IVBH uses a central discovery platform to build multiple health franchises
🔹 Why cell-free RNA could offer advantages for earlier disease detection
🔹 How LDTs, cash-pay models and new diagnostic “storefronts” could reshape commercialisation
🔹 What investors looked for when Mammogen raised its Series A

Chapters:
01:02 Introduction and Marty Keiser’s background
03:22 Moving from capital markets into diagnostics
08:20 Building the IVBH business model differently
11:27 Surviving the biotech downturn and changing capital markets
16:09 The science behind IVBH’s cell-free RNA platform
20:06 LDTs, cash-pay testing and new commercial models
26:13 What helped Mammogen secure its Series A
30:26 Future milestones and rethinking diagnostics growth

Guest: Marty Keiser
Founder & CEO, IVBH
LinkedIn: https://www.linkedin.com/in/martykeiser

Host: David Filby
Founder and CEO of Elevra Consulting
LinkedIn: https://www.linkedin.com/in/davidfilby/

🔔 Subscribe to Diagnosing Dx for weekly conversations with leaders shaping the future of diagnostics and omics.

In this episode of Diagnosing Dx, David Filby is joined by Raymond Tarr, Founder of Sagacity Diagnostics.

Raymond brings more than 25 years of experience across diagnostics, rare disease, commercialisation and patient finding, with previous roles spanning companies including Cepheid and AstraZeneca/Alexion. His experience in rare disease, both professionally and personally, ultimately led to the creation of Sagacity Diagnostics and its PathfindEHR platform.

Raymond explains how PathfindEHR is designed to help clinicians identify patients who may be undiagnosed, misdiagnosed or missing the right testing by making better use of data already sitting within electronic health records.

We also discuss the adoption challenge facing diagnostics companies, how better workflow integration could drive more appropriate testing, and why education and awareness can be just as important as developing the test itself.

Key takeaways:
🔹 Why existing EHR data could help shorten the diagnostic journey
🔹 How PathfindEHR helps identify suspect and potentially misdiagnosed patients
🔹 Why better workflow integration can increase appropriate diagnostic testing
🔹 How diagnostics companies can benefit from stronger clinician education and adoption tools
🔹 Why rare disease is only the starting point for Sagacity’s wider ambitions

Chapters:
00:59 Introduction and Raymond Tarr’s background
05:46 Moving from diagnostics into rare disease
08:57 The personal experience behind Sagacity Diagnostics
11:00 How PathfindEHR works
17:49 Using EHR data to identify patients who need testing
23:16 How diagnostics companies can benefit from the platform
29:16 Commercialisation and early market traction
34:40 Future milestones and scaling Sagacity

Guest: Raymond Tarr
Founder, Sagacity Diagnostics
LinkedIn: https://www.linkedin.com/in/raymondtarr/

Host: David Filby
Founder and CEO of Elevra Consulting
LinkedIn: https://www.linkedin.com/in/davidfilby/

🔔 Subscribe to Diagnosing Dx for weekly conversations with leaders shaping the future of diagnostics and omics.

In this episode of Diagnosing Dx, David Filby is joined by Robert Carlson, Founder and President of Life Science Dx Consulting.

Robert brings 30 years of experience across diagnostics and life sciences, spanning scientific, commercial, corporate development and executive leadership roles.

He explains why early-stage diagnostics companies should think about partnerships much earlier, not only as a source of funding but as a way to build credibility, strengthen commercial strategy and create new routes to market.

The conversation also covers reimbursement, market access, investor expectations and why strong science alone is rarely enough to build a successful diagnostics company.

Key takeaways:
🔹 Why diagnostics founders should consider partnerships before they urgently need them
🔹 How strategic partnerships can strengthen a future fundraising story
🔹 Why fear around IP, dilution and losing control can hold founders back
🔹 The importance of understanding reimbursement and market access early
🔹 Why commercial strategy should develop alongside the science

Chapters:
00:56 Introduction and Robert Carlson’s background
05:40 Why partnerships matter in early-stage diagnostics
12:19 Using partnerships to strengthen fundraising
14:51 Why founders hesitate to partner early
19:29 IP, control and the fear of being locked in
25:29 Why great science alone isn’t enough
28:43 Reimbursement, regulatory strategy and investor expectations
35:18 Building the right commercial strategy from the start

Guest: Robert Carlson
Founder and President, Life Science Dx Consulting
LinkedIn: https://www.linkedin.com/in/robertwcarlsonsr/

Host: David Filby
Founder and CEO of Elevra Consulting
LinkedIn: https://www.linkedin.com/in/davidfilby/

🔔 Subscribe to Diagnosing Dx for weekly conversations with leaders shaping the future of diagnostics and omics.

In this episode of Diagnosing Dx, David Filby is joined by Octavian Florescu, CEO of In Diagnostics.

An electrical engineer and microchip designer by training, Octavian has spent his career exploring how semiconductor technology can be applied to blood testing. After building and exiting his first diagnostics company, he took those lessons into In Diagnostics alongside his co-founder and wife, Ana.

Octavian explains how the company is developing microchip-based blood testing from a drop of blood, why they are launching first in the veterinary market, and how a two-person “minimum viable company” is working towards profitability before expanding further into human diagnostics.

We also discuss what founders learn when capital is scarce, why diagnostics may need different funding models, and how better access to longitudinal blood data could support more personalised healthcare.

Key takeaways:
🔹 Why Octavian believes blood testing should become more frequent and accessible
🔹 How lessons from his first diagnostics company shaped In Diagnostics
🔹 Why the veterinary market offers an early route to revenue and product validation
🔹 The thinking behind building a two-person “minimum viable company”
🔹 Why diagnostics funding may need to move beyond traditional venture timelines

Chapters:
01:02 Introduction and Octavian Florescu’s background
04:32 From microchip design to blood testing
06:33 Lessons from his first diagnostics company
11:20 Building In Diagnostics as a minimum viable company
13:52 Microchip-based blood testing and the unmet need for more data
19:15 Launching first in veterinary diagnostics
22:27 Building towards profitability without traditional VC funding
29:53 Upcoming milestones and the future of diagnostics

Guest: Octavian Florescu
CEO, In Diagnostics
LinkedIn: https://www.linkedin.com/in/octavian-florescu-51b28817/

Host: David Filby
Founder and CEO of Elevra Consulting
LinkedIn: https://www.linkedin.com/in/davidfilby/

🔔 Subscribe to Diagnosing Dx for weekly conversations with leaders shaping the future of diagnostics and omics.

In this episode of Diagnosing Dx, David Filby is joined by Nicole Bell, CEO of Galaxy Diagnostics.

Nicole’s route into vector-borne disease diagnostics is deeply personal. After her husband was initially diagnosed with early-onset Alzheimer’s disease, she continued searching for answers and later discovered he had Lyme disease alongside Babesia and Bartonella infections.

That experience led Nicole to Galaxy Diagnostics, where the company is working to improve direct detection of vector-borne infections using approaches including urine antigen testing and high-sensitivity PCR.

Nicole discusses why these infections are so difficult to diagnose, how outdated and antibody-based testing can leave patients without clear answers, and Galaxy’s plans to take its Lyme urine antigen test through clinical studies towards FDA submission.

Key takeaways:
🔹 Why Lyme, Bartonella and Babesia can be particularly difficult to detect
🔹 The limitations of relying on antibody testing for active infection
🔹 Why vector-borne disease exposure extends far beyond obvious tick bites
🔹 How Galaxy Diagnostics is approaching direct pathogen detection
🔹 The company’s path towards FDA approval, reimbursement and broader adoption

Chapters:
00:57 Introduction and Nicole Bell’s background
02:43 The personal story behind Nicole’s move into vector-borne diagnostics
08:17 Why vector-borne infections are so difficult to diagnose
13:28 Galaxy Diagnostics and its direct detection approach
17:22 How widespread is the vector-borne disease problem?
22:05 Commercialisation, clinical studies and the path to FDA approval
27:13 Raising a Series A in a difficult diagnostics market
31:31 Upcoming milestones and the future of diagnostics

Guest: Nicole Bell
CEO, Galaxy Diagnostics
LinkedIn: https://www.linkedin.com/in/nicoledaniellebell/

Learn more about Galaxy Diagnostics: https://www.galaxydx.com/

Host: David Filby
Founder and CEO of Elevra Consulting
LinkedIn: https://www.linkedin.com/in/davidfilby/

🔔 Subscribe to Diagnosing Dx for weekly conversations with leaders shaping the future of diagnostics and omics.

In this episode of Diagnosing Dx, David Filby is joined by Andrew Miller, a diagnostics founder, advisor and two-time exited CEO.

A scientist by training, Andrew founded and led companies focused on rapid molecular diagnostics, taking Ionian Technologies through acquisition by Alere and later building NAT Diagnostics, which was acquired by Becton Dickinson in 2020. The technology developed at Ionian ultimately became central to Abbott’s ID NOW platform.

Andrew shares what he learned from going through the acquisition process twice, why his second company was designed for sale from the outset, and the four risks he believes every diagnostics founder needs to manage: technology, operations, finance and commercial relevance.

Key takeaways:
🔹 What Andrew learned from two successful diagnostics exits
🔹 Why Ionian chose acquisition rather than funding the full journey to FDA approval
🔹 How the lessons from his first exit shaped NAT Diagnostics from day one
🔹 Why founders need to prepare for due diligence long before an acquisition process begins
🔹 The four risks Andrew uses to assess early-stage diagnostics companies

Chapters:
00:00 Introduction and Andrew Miller’s background
02:23 Two diagnostics exits and the opportunity in rapid molecular testing
04:03 Building Ionian Technologies
08:37 Why Ionian pursued an acquisition
15:00 Building NAT Diagnostics differently the second time
19:04 Designing a diagnostics company for acquisition
27:03 Advising founders and the four risks every startup faces
31:33 Where diagnostics is heading next

Guest: Andrew Miller, PhD
Diagnostics Founder, Advisor & Two-Time Exited CEO
LinkedIn: https://www.linkedin.com/in/andrew-miller-2670811/

Host: David Filby
Founder and CEO of Elevra Consulting
LinkedIn: https://www.linkedin.com/in/davidfilby/

🔔 Subscribe to Diagnosing Dx for weekly conversations with leaders shaping the future of diagnostics and omics.

In this episode of Diagnosing Dx, David Filby is joined by Travis Wold, Chief Executive Officer at Imagenomix.

Travis brings experience across cancer diagnostics, genomics, liquid biopsy, and international commercialization. We explore how Imagenomix is using AI to help make genomic testing more accessible to cancer patients globally.

With around 98% of cancer patients outside the US not receiving NGS testing, Travis explains how analysing standard H&E pathology images could help identify patients who are more likely to benefit from confirmatory genomic testing.

We also discuss Imagenomix’s commercial strategy, digital pathology partnerships, and the longer-term potential for AI to support more precise treatment decisions in oncology.

Key takeaways:
🔹 Why access to genomic testing remains extremely limited outside the US
🔹 How Imagenomix uses AI to identify mutation signals from standard H&E pathology images
🔹 Why AI screening could reduce the cost and volume of unnecessary NGS testing
🔹 How digital pathology partnerships could help Imagenomix scale globally
🔹 Why predicting treatment response could become the next major step for AI in precision oncology

Chapters:
00:59 Introduction and Travis Wold’s background
05:29 From cancer diagnostics to the global genomic testing problem
09:42 The limitations of NGS and where AI fits into the workflow
13:36 Imagenomix’s mission and the 98% genomic testing gap
17:42 Funding, digital pathology partnerships, and commercial traction
20:36 Regulatory strategy, screening, and the path towards companion diagnostics
23:13 Can AI predict which cancer patients will respond to treatment?
32:56 Scaling Imagenomix globally and the milestones ahead

Guest: Travis Wold
Chief Executive Officer at Imagenomix

LinkedIn: https://www.linkedin.com/in/travisjwold/

Host: David Filby
Founder and CEO of Elevra Consulting
LinkedIn: https://www.linkedin.com/in/davidfilby/

🔔 Subscribe to Diagnosing Dx for weekly conversations with leaders shaping the future of diagnostics and omics.

In this episode of Diagnosing Dx, David Filby is joined by Nedal Safwat, Senior Vice President of Medical Diagnostics at Canatu and President of Canatu Inc.

With more than 20 years in diagnostics, Nedal has held leadership roles across Cepheid, QIAGEN, bioMérieux and Luminex. He now leads Canatu’s expansion into medical diagnostics, taking the company’s carbon nanotube technology into point-of-care testing.

Nedal explains why Canatu has chosen hormone testing and sepsis as its first areas of focus, and why the company started with the unmet clinical need rather than trying to find an application for its technology.

We also discuss the opportunity for faster hormone testing, the shift towards decentralised diagnostics, reimbursement and design-to-cost, and how Canatu is combining the speed of a startup with the infrastructure and backing of an established company.

Key takeaways:
🔹 Why Canatu is bringing carbon nanotube technology into medical diagnostics
🔹 Why hormone testing and sepsis were selected as the company’s first focus areas
🔹 Why diagnostics companies should start with the unmet need and work backwards
🔹 How point-of-care hormone testing could improve convenience and reduce patient drop-off
🔹 Why reimbursement, cost and customer validation need to be considered from the beginning

Chapters:
00:53 Introduction and Nedal Safwat’s background
07:18 Canatu and the move into medical diagnostics
13:02 Why hormone testing and sepsis?
17:26 Starting with the unmet need and product-market fit
21:29 Partnerships, personalised hormone testing and patient demand
27:52 Product development and the path to commercialisation
32:57 Reimbursement, design-to-cost and startup culture
40:30 Future milestones and the diagnostics market outlook

Guest: Nedal Safwat
Senior Vice President, Medical Diagnostics at Canatu
President, Canatu Inc.

LinkedIn: https://www.linkedin.com/in/nedal-safwat/

Learn more about Canatu, Medical Diagnostics here: https://canatu.com/products/medical-diagnostics/

Host: David Filby
Founder and CEO of Elevra Consulting
LinkedIn: https://www.linkedin.com/in/davidfilby/

🔔 Subscribe to Diagnosing Dx for weekly conversations with leaders shaping the future of diagnostics and omics.